Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF

November 15, 2012 updated by: Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure

Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).

A total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • 2ndChongqingMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
  • Patients with hypertensive history were at least 5 years. Systolic pressure > 140mmHg, < 190mmHg, Diastolic pressure > 85mmHg. < 110mmHg.
  • 40 < Age < 65 years

Exclusion Criteria:

  • Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening
  • Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
  • Direct current (DC) cardioversion within the last 3 months
  • Symptomatic bradycardia
  • Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
  • Cardiac surgery or cardiac catheter ablation within the last 3 months
  • Typical angina pectoris symptoms at rest or during exercise
  • Known coronary artery disease with indication for intervention
  • Valvular disease > II degree
  • Left ventricular ejection fraction < 40%
  • Diastolic blood pressure > 110mm Hg at rest
  • Symptomatic arterial hypotension
  • Known renal artery stenosis
  • Serum creatinine > 1.8 mval/l
  • Relevant hepatic or pulmonary disorders
  • Hyperthyroidism manifested clinically and in laboratory
  • Known drug intolerance for AT II inhibitors
  • Females who are pregnant or breast feeding
  • Females of childbearing potential who are not using a scientifically accepted method of contraception
  • Participation in a clinical trial within the last 30 days
  • Drug addiction or chronic alcohol abuse
  • Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
  • Evidence of an uncooperative attitude

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nifedipine
Patients in arm 1 receive Nifedipine;
Drug: Nifedipine,
Nifedipine 30-60mg/day
Other Names:
  • anti-hypertensive drugs, Atrial fibrillation
Active Comparator: Telmisartan
Arm 2 receive telmisartan
Drug: Telmisartan
Telmisartan 80-160mg/day
Other Names:
  • anti-hypertensive drugs, atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Atrial Fibrillation
Time Frame: four years
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Investigators

  • Study Chair: Yuehui Yin, MD, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTP-AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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